Everything You Need To Know About Mavyret

mavyret

Mavyret is a hybrid of different pan-genotypic

It has direct-acting antiviral drugs that target different phases. 

The phases are for the hepatitis C virus life cycle

Below are the two direct-acting antiviral drugs:

1) Glecaprevir (an NS3/4A protease inhibitor;

2) Pibrentasvir (an NS5A inhibitor).

Glecaprevir

An NS3/4A protease inhibitor for the hepatitis C virus (HCV), glecaprevir.

It is crucial for viral replication. 

It requires the proteolytic cleavage of the hepatitis C virus-coding polyprotein. 

It is for constant conversion to mature versions of the NS3, NS4A, NS4B, NS5A, and NS5B proteins.

The recombinant hepatitis C virus proteases NS3/4A from clinical isolates. 

They are of the virus genotypes la, lb., 2a, 2B, Za, 4a, 5a, and 6a. 

Glecaprevir inhibits them in biochemical experiments, with IC50 values. 

It ranges from 3.5 to 11.3 nm.

Pibrentasvir

The hepatitis C virus NS5A protein is necessary for viral RNA replication. 

It is also necessary for virion assembly. 

The drug pibrentasvir inhibits it on a pan-genotypic level.

The mechanism of action of pibrentasvir was studied.

It was in the course of investigations into antiviral activity in cell cultures. 

Further, it was an investigation into the nature of the drug resistance. 

Gender/body weight

Based on a patient’s gender or weight, one can’t change Mavyret dosage. 

Elderly patients

In senior people, Mavyret dose change is not necessary.

Age 

It is not an important factor in the population pharmacokinetic analysis. 

It is for HCV-infected patients between the ages of 18 and 88.

Patients with impaired renal function

In individuals without HCV who had: 

1) Mild, moderate, or severe renal impairment;

2) Who didn’t undergo dialysis.

The AUC values of Glecaprevir and Pibrentasvir increased. 

It is by no more than 56% in comparison to patients with normal renal function.

mavyret

Patients: 

1) Without HCV getting dialysis;

2) Those not were comparable to the AUC.

The values of Glecaprevir and Pibrentasvir (Difference 18%).

In a population pharmacokinetic investigation: 

1) Patients with HCV with end-stage renal failure, with or without dialysis.

It all had Glecaprevir AUC values that were 86% higher. 

And, Pibrentasvir AUC values were 54% higher. 

Patients whose renal function is normal.

Unbound Glecaprevir and Pibrentasvir concentrations in MRI may: 

1) Exhibit a more dramatic rise in AUC.

All in all, there were no meaningful changes in Mavyret exposure. 

It is in HCV-infected individuals with compromised renal function on and off dialysis.

Hepatic insufficiency patients

Patients with Child-Mew class A hepatic insufficiency had an AUC of Glecaprevir. 

That was 33% higher. 

Class 13 patients had an AUC of 100%. 

And, Class C Patients had an AUC that was 11 times greater than in patients without HCV. 

It goes the same with normal liver function too.

The AUC of Pibrentasvir did not alter in patients with Child-Pugh. 

It is with Class A Hepatic Insufficiency. 

It increased by 114 percent in patients with Class C and by 26 percent for Class B Hepatic Insufficiency.

Unbound Glecaprevir and Pibrentasvir concentrations may result in a more dramatic increase. 

It’s in AUC.

After taking Mavyret, population pharmacokinetic analysis gets revealed. 

Glecaprevir had an effect that was around two times greater than Pibrentasvir. 

It is in individuals with HCV and compensated cirrhosis of the liver.

It is uncertain what causes the differences in Glecaprevir Exposure. 

It is between patients with chronic Hepatitis C and cirrhosis.

VERY CAUTION

Do not combine Mavyret with: 

1) Omeprazole (40 mg);

2) Darunavir/Ritonavir;

3) Efavirenz;

4) Lopinavir/Ritonavir;

5) Cyclosporine (>100 mg per day).

It’s not advised at all.

Take Mavyret with the best care with the following medications:

1) Digoxin;

2) Pravastatin;

3) Rosuvastatin;

4) Flu-Vastatin;

5) Pita-Vastatin;

6) Tacrolimus.

 

USE WHILE PREGNANT OR LACTATING

There is no data on the usage of glecaprevir or pibrentasvir in pregnant women.

Less than 300 pregnancies occurred during the research period.

Glecaprevir and Pibrentasvir didn’t show any direct harmful effects. 

It is on reproductive function in studies in rats and mice.

Glecaprevir is represented to have toxic effects on a pregnant female. 

It is a constant miscarriage in rabbits, which precluded further investigation.

The medication Mavyret is not advised for usage during pregnancy as a precaution.

Breast-feeding period

It is unknown:

1) If Pibrentasvir or Glecaprevir gets secreted in breast milk.

Since Pibrentasvir and Glecaprevir get excreted in milk, according to the available evidence. 

It is from animal pharmacokinetic studies. 

One can not rule out the risk to infants and young children in their first year of life.

You can consider deciding whether to stop or refrain from Mavyret therapy when:

1) The ratio of the benefits of breastfeeding for the infant and the benefits of the therapy for the woman.

Fertility

There’s no study about how Glecaprevir and/or Pibrentasvir affect human fertility.

Animal tests didn’t represent a detrimental impact on fertility:

1) When exposure levels of Glecaprevir or Pibrentasvir surpass those attained in people. 

It is after taking the prescribed dosage of the medications.

Dosage and administration method

For administration through the mouth.

Do not chew the tablets. 

Do not crush or break. 

Eat it as a whole while eating.

A doctor with experience treating people with chronic hepatitis C should prescribe Mavyret. 

He should oversee your treatment while you are taking it. 

Doses

You can take Mavyret once a day with meals at a dose of 300 mg/120 mg (three tablets of 100 mg/40 mg).

If you forget to take the medication Mavyret, you can still take it within 18 hours of the scheduled time.

Do not take the missed dosage of Mavyret if more than 18 hours passed. 

Since the scheduled time to take it; instead, wait until the scheduled time of the next dose.

Don’t take the medication twice.

You should administer a second dosage of Mavyret. 

It is when vomiting develops within three hours of taking the medication.

The second dosage of Mavyret is not necessary if vomiting occurs more than three hours after taking it.

Use in elderly patients

Mavyret dosage modification is not necessary for senior people.

Patients with impaired renal function

Mavyret dosage modification is not necessary for individuals. 

It is for those with renal impairment, including those receiving dialysis.

Patients with impaired liver function

In individuals with moderate hepatic impairment (Child-Pugh Class A):

Mavyret doses do not need to adjust.

Patients with severe hepatic insufficiency should not use the medication Mavyret. 

And, those with moderate hepatic insufficiency (Child-Pugh Class B) should not either. 

Mavyret is yet to test in children and adolescents. 

It is under the age of 18 to determine its safety and effectiveness.

Patients after liver transplantation

Following a liver transplant: 

Patients should get Mavyret treatment for at least 12 weeks.

Patients with genotype 3 had Peg-IFN + Ribavirin (with or without sofosbuvir). 

Or, Sofosbuvir + Ribavirin therapy. 

One can think about prolonging the course of treatment (for 16 weeks).

Patients with HCV/HIV-1 co-infection

Recommendations for Mavyret dose when used with medications for the treatment of HIV-1.

Side effect

Based on the outcomes of phases 2 and 3 trials including over 2,300 individuals infected with HCV: 

They are 1, 2, 3, 4, 5, or 6. 

The safety of Mavyret got evaluated in patients with compensated liver function. 

It is with or without cirrhosis.

treated for 8, 12, or 16 weeks with Mavyret.

Headaches and weariness were the most frequent negative effects (frequency > 10%).

Less than 0.1 percent of people on Mavyret experienced severe side effects. 

It is a transient ischemic attack.

The percentage of patients who quit taking Mavyret was 0.1 percent.

It is with those who started to experience side effects.

People with liver cirrhosis experienced adverse effects:

It is of a similar nature and degree to patients without hepatic cirrhosis.

And, adverse effects in those on hemodialysis, and those with severe renal impairment:

1) 104 individuals had their safety with Mavyret in patients with compensated hepatic. 

It is with or without cirrhosis of the liver and chronic infection with hepatitis C virus. 

It can be genotypes 1, 2, 3, 4, or 5 assessed.

These patients included those on dialysis.

The most frequent side effects (12 percent):

1) It is in individuals with severe renal impairment, pruritus (17%), and weariness.

mavyret

OVERDOSE

For Glecaprevir, the max. a recorded dose taken by healthy volunteers was 1200 mg once daily. 

It is for seven days. 

While for Pibrentasvir, it was 600 mg once daily for ten days. 

One out of every 70 healthy volunteers took many doses of Glecaprevir (700 mg or 800 mg).

It is once a day for >7 days. 

They say an asymptomatic rise in blood ALT (>5 times ULN).

In the event of an overdose, it is important to keep an eye out for any symptoms of toxic harm in the patient.

The proper symptomatic therapy should start right away.

The body’s release of glecaprevir and pibrentasvir is only aided by hemodialysis.

Interactions with other drugs

Glecaprevir and Pibrentasvir inhibits:

1) Organic Anion Transport Polypeptide (OATP) 1B1/3;

2) P-Glycoprotein (P-GP);

3) Breast Cancer Resistance Protein (BCRP).

And, examples of medications are:

1) Dabigatran Etexylate;

2) Digoxin; 

3) Rosuvastatin;

4) OATP1B1/3

May see an increase in plasma concentrations. 

During the use along with Mavyret. 

Contact your doctor for advice on how to avoid medication interactions. 

It is with the P-Glycoprotein Substrates BCRP and OATP1B1/3.

It is in regard to other P-glycoprotein substrates.

You may need to change the dosage for BCRP and OATP1B1/3.

Glecaprevir and Pibrentasvir inhibits: 

1) The cytochrome P450 Isoenzymes CYP3A;

2) Uridine-Glucuronosyltransferase (UGT) 1A1.

Sensitive CYP3A substrates (Midazolam, Felodipine) and UGT1A1 (Ralgegravir) didn’t result. 

It is when given in combination with Mavyret. 

It didn’t result in a meaningful increase in systemic exposure.

In vitro, the bile acid exporting pump (BSEP) gets inhibited. 

It is by the use of Glecaprevir and Pibrentasvir.

Patients using antagonists of vitamin K

Mavyret therapy may cause changes in Liver Function. 

Do careful monitoring of the international normalized ratio (INR) for sure.

Mavyret potential interactions with other drugs.

Co-administration of SURZA with potent P-glycoprotein inducers.

The concentration of Glecaprevir and Pibrentasvir in blood plasma can: 

Decrease by medications that induce P-glycoprotein and CYP3A, such as:

A) Rifampicin;

B) Carbamazepine;

C) St. John’s wort (Hypericum Perforatum);

D) Phenobarbital;

E) Phenytoin;

F) Primidone.

This can reduce the therapeutic effect of Mavyret. 

It can cause a loss of the Virological response. 

It is not advised to use these medications at the same time as Mavyret.

Drugs that increase P-glycoprotein and CYP3A may result in: 

Reduction in the construction of Glecaprevir and Pibrentasvir in the plasma.

They can be Oxcarbazepine, Eslicarbazepine, Lumacaftor, and Crizotinib.

It is not advised to utilize mild inducers together.

The substrates of the drugs Glecaprevir and Pibrentasvir are:

The efflux carriers of P-glycoprotein and/or BCRP.

Additionally, the hepatic uptake transporters OATP1B1 and 3 are substrates for glecaprevir.

If you combine Mavyret with medications that inhibit P-Glycoprotein and BCRP, may: 

1) Delay the clearance of Glecaprevir and Pibrentasvir. 

2) Increase the exposure of blood plasma to antiviral medications. 

And, such medications can be:

1) Cyclosporine;

2) Cobicistat;

3) Dronedarone;

4) Itraconazole;

5) Ketoconazole;

6) Ritonavir.

Elvitegravir, Cyclosporine, Darunavir, and Lopinavir are examples of medications. 

That are OATP1B1/3 inhibitors. 

They may enhance the systemic concentration of Glecaprevir. 

Direct-acting antiviral medication G1PPD

Rifampicin’s impact on glecaprevir and pibrentasvir 24 hours after the final dosage.

Consider how Atazanavir and Ritonavir will affect the initial dosage. 

It is of the Glecaprevir and Pibrentasvir.

Patients who lacked cyclosporine treatment were:

The patients with HCV infection who underwent transplantation. 

They took cyclosporine at a dosage of 100 mg daily or less experienced four times. 

It is for Glecaprevir exposure.

The following medications were the subjects of many drug-drug interaction studies.

1) Abacavir;

2) Amlodipine;

3) Buprenorphine;

4) Caffeine;

5) Dextromethorphan;

6) Dolutegravir;

7) Emtricitabine;

8) Felodipine;

9) Lamivudine;

10) Lamotrigine;

11) Methadone;

12) Midazolam;

13) Naloxone;

14) Norethindrone;

15) Or, other contraceptives containing progestin, Rilp. 

No medical interaction was found.

SPECIAL INSTRUCTIONS

Hepatitis B virus reactivation

During the course of direct-acting antiviral therapy, something got observed.

It was that the hepatitis B virus was to reactivate with catastrophic results.

For all patients, before beginning treatment, HBV screening requires.

For patients who have HBV/HCV co-infection, one should do the monitoring. 

It is with current recommendations since they run the risk of having HBV reactivate.

Patients after liver transplantation

In patients getting liver transplants, Mavyret didn’t get tested for its effectiveness. 

Plus, it is the same on the safety levels too.

An evaluation of the possible advantages and disadvantages for every patient should use.

It is to determine how to treat them with Mavyret in line with the advised dose and administration.

Impaired liver function

Patients with severe hepatic insufficiency should not use the medication Mavyret. 

Those with moderate hepatic insufficiency (Child-Pugh Class B) should not either. 

Patients who did not improve after receiving NS5A and/or NS3/4A inhibitors. 

It is part of their prior therapy.

A study determined the likelihood of acquiring resistance to Glecaprevir/Pibrentasvir. 

It goes with patients with genotype 1 viral infections and a small number of patients. 

That’s with genotype 4 virus infections that didn’t respond to the prior medication. 

That’s all about the regimen that got determined in the study.

As anticipated, the therapeutic failure was at high risk. 

It was for the individuals who got treatment with both types of medicines. 

They are NS3/4A and NS5A inhibitors.

It’s not clear how to predict treatment failure using baseline information. 

It is on therapeutic resistance.

The key finding was the development of resistance to both types of medications. 

It happened in patients who didn’t react to Glecaprevir/Pibrentasvir treatment.

There are no data on individuals treated for viral infections of genotypes 2, 3, 5, and 6.

Do not use Mavyret to treat patients who got therapy with NS3/4A and/or NS5A inhibitors.

Influence on one’s capacity to operate machinery and vehicles

Driving a car and operating machinery doesn’t affect by the Mavyret medication.

RELEASE FORM

Tablets covered with film. 100 mg + 40 mg.

Three film-coated pills get packed in an aluminum foil.

And, they are polyvinyl chloride, polyethylene, and polychlorotrifluoroethylene blister.

A pack of cardboard has 4 packs of cardboard. 

It is usually with usage instructions, and a pack of cardboard contains 7 blisters.

Expiry Date

Age 2 years

After the expiry date is printed on the package, do not use it.

STORAGE CONDITIONS

At a temperature that does not go over 25 °C.

Keep out of children’s reach.

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